Relexxii

Treats Attention Deficit Hyperactivity Disorder (ADHD). NDA 216117, held by Osmotica Pharm US. Methylphenidate Hydrochloride.

As of Nov 13, 2026, NDA 216117 (Relexxii), held by Osmotica Pharm US, was first approved by FDA on Jun 23, 2022, with 2 approved supplements and 0 published complete response letters.

First approved: Jun 23, 2022
Review: Standard
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

RELEXXII is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults (up to the age of 65 years) and pediatric patients 6 years of age and older. Limitations of Use The use of RELEXXII is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jun 23, 2022	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Products

7 strengths and forms


Relexxii18MG · tablet, extended release;oral	Methylphenidate Hydrochloride	RxReference drug
Relexxii27MG · tablet, extended release;oral	Methylphenidate Hydrochloride	RxReference drug
Relexxii36MG · tablet, extended release;oral	Methylphenidate Hydrochloride	RxReference drug
Relexxii45MG · tablet, extended release;oral	Methylphenidate Hydrochloride	RxReference drug
Relexxii54MG · tablet, extended release;oral	Methylphenidate Hydrochloride	RxReference drug
Relexxii63MG · tablet, extended release;oral	Methylphenidate Hydrochloride	RxReference drug
Relexxii72MG · tablet, extended release;oral	Methylphenidate Hydrochloride	RxReference drug

All 3 submissions, including labeling and manufacturing supplements


Sep 23, 2025	Supplement 3Labeling · Standard review	Approved	Letter Label Medication Guide
Oct 13, 2023	Supplement 1Labeling · Standard review	Approved	Label
Jun 23, 2022	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 216117
Drugs@FDA: Overview at FDA
Company: Osmotica Pharmaceuticals US

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters